Delta-Fly Pharma Inc.: Phase I/II Combo-study of DFP-10917 with Venetoclax in Patients with AML Initiates Enrollment of Patients
Delta-Fly Pharma Inc.: Phase I/II Combo-study of DFP-10917 with Venetoclax in Patients with AML Initiates Enrollment of Patients
Following to the previous information on April 8th. 2024, we are excited to share our latest development status.
A Phase I/II clinical trial of DFP-10917 in combination with Venetoclax (VEN) in patients with acute myeloid leukemia (AML) who had one prior treatment with VEN involved regimen was approved by the US Food and Drug Administration (FDA) on April 8 this year (Delta-Fly Pharma Inc.: Notice of Authorization to Conduct the Phase I/II Study of DFP-10917 combined with Venetoclax | Business Wire). Subsequently, we are pleased to announce that the first patient was enrolled at the University of Virginia Hospital based on the approval of the Investigational Review Board (IRB). The University of Virginia Hospital is the clinical site that enrolled the most patients to the Phase III study of DFP-10917 monotherapy in patients with failed/relapsed AML.
Some pharmaceutical companies have already expressed interest in the Phase III study of DFP-10917 monotherapy. Additionally, many companies including mega pharmaceutical companies, have showed interest in the Phase I/II combo-study of DFP-10917 and VEN, because of the large potential market size in the treatment of AML.
VEN itself is not effective against AML but effective when combined with Azacitidine (DNA methylation inhibitor), which is known a standard AML therapy at present despite safety concerns were reported. Accordingly, we are going to supply much more welcome combo-therapy of VEN and DFP-10917 (G2/M arrest) comparing to current standard AML therapy. 39 patients at maximum will be enrolled to this study. The endpoints of this study are CR (complete remission) rate and PFS (progression-free survival). After successful completion of this Phase I/II study, Delta-Fly Pharma, Inc. will cooperate with a mega pharmaceutical company objective NDA (New Drug Application).
Please take notice of our own innovative approach for miserable cancer patients and contact with us.
Inquires
Yasundo Yamasaki, Ph.D.
Business Development
Delta-Fly Pharma, Inc.
Head office: Tokushima 771-0117, Japan
Phone: +81-3-6231-1278
E-mail: yyamasaki1206@delta-flypharma.co.jp
Home page: https://www.delta-flypharma.co.jp/en/
View source version on businesswire.com: https://www.businesswire.com/news/home/20240910878901/en/
-
What’s Happening in the Markets This Week
-
Worst-Performing Stock ETFs of the Quarter
-
Q3 in Review and Q4 2024 Market Outlook
-
Top-Performing Stock ETFs of the Quarter
-
September Jobs Report Forecasts Show Moderate Hiring Gains
-
Port Strike a Headache for Shippers but a Potential Tailwind for Certain US Transport Stocks
-
13 Charts on Q3′s Roller-Coaster Rally for Stocks and Bonds
-
5 Stocks to Buy Instead of Overpriced US Equities
-
Consumer Defensives: Despite Angst, Thirsty Investors Have Names to Pursue
-
Industrials: Many Stocks Overvalued After Q3 Outperformance
-
Basic Materials: Despite Index Rise, We See Multiple Long-Term Opportunities
-
What the Election Could Mean for Big Tech Stocks
-
3 Lessons From Recent Stock Market Drama
-
Consumer Cyclicals: Even Amid Moderating Consumer Spending, We See Discounts
-
Healthcare: Valuations Look Fair Overall, With Select Industries Still Undervalued
-
Utilities: Falling Interest Rates, Growth Outlook Boosting Stocks